A Controlled Trial to Evaluate the Effects of GanedenBC30 on the Immune System

• Improvement in CD4 cell counts. [ Time Frame: 90 days. ] [ Designated as safety issue: No ]
  Laboratory blood tests of CD4 lymphocytes.
• Improvement of gastrointestinal symptoms. [ Time Frame: 30, 60, and 90 days. ] [ Designated as safety issue: No ]
  Measure improvement in GSRS questionnaire scores.

Improvement in the rate of bacterial translocation may lead to a decrease in a chronic inflammatory response thereby decreasing CD4 destruction and HIV proliferation.

By the addition of probiotics we hope to show a reduction in LPS leading to a decrease in chronic inflammation and therefore an improvement in immune markers.

• HIV Infection
• Gastrointestinal Symptoms

• Dietary Supplement: GanedenBC30, GBI-30, PTA-6086
  1 capsule per day containing 2 billion CFU of GanedenBC30, GBI-30, PTA-6086 for 90 days.
  Other Names:

  • Bacillus coagulans
  • Probiotics
• Drug: Placebo
  1 capsule per day for 90 days.

• Experimental: GanedenBC30, GBI-30, PTA-6086
  Intervention: Dietary Supplement: GanedenBC30, GBI-30, PTA-6086
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

Inclusion Criteria:

• Patient is male or non-pregnant, non-lactating female.
• Adults 18 years or older.
• Is able to provide written, informed consent to participate in the study.
• Serological documentation of HIV infection at any time prior to study entry and is clinically stable.
• Stable CD4 count greater than or equal to 250 cells/cubic mm for six months prior to study entry (+/- 50 cells/cubic mm).
• HIV-1 RNA ≤50 copies/mL for six months prior to study entry.
• Karnofsky performance status - 60%.

• Adequate laboratory parameters within the last 30 days:

  1. absolute neutrophil count >1000 cells/cubic mm
  2. hemoglobin >9.0 g/dL
  3. platelets >75,000/cubic mm
  4. creatinine <1.5 x upper limit of normal
  5. SGOT/SGPT <3.0 x upper limit of normal
  6. bilirubin <2.0 mg/dL
• Patients with documented GI symptoms to include but are not limited to: flatulence, diarrhea, bloating, gastroesophageal reflux disease, nausea, and constipation.
• If females are of childbearing potential, they must be practicing an effective method of contraception and agree to use birth control while on protocol and for 1 month after completion of study. Women of Child Bearing Potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to start of study medication. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not. postmenopausal [defined as amenorrhea for 12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL]. Even women who are using oral, implanted or, injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential.
• Must agree to practice protected sexual activity (via barrier method) during course of the study.
• In the opinion of the investigator, is willing and able to comply with the study requirements.

Exclusion Criteria:

• Active opportunistic infection, which is progressive, or imminently disabling or life threatening, in the judgment of the Principal Investigator with exception of Kaposi Sarcoma.
• Cytotoxic chemotherapy, interferon treatment, or radiation therapy within the preceding 3 weeks (subjects who have received intralesional chemotherapy will not be excluded, however).
• Any antibiotic therapy within 30 days of enrollment
• Any probiotic formulation within 30 days of enrollment
• Any immunization within 30 days of enrollment
• Known history of allergic reactions to any of the investigational products or their ingredients.
• Chronic treatment with immunosuppressant drugs, including corticosteroids, except for the treatment of adrenal insufficiency. Topical steroids are permitted.
• History of or known current malabsorption syndrome.
• Any grade 3 or 4 lab abnormalities as defined by a standardized grading scheme based on the DAIDS table (see Appendix B) with the following exceptions:
• Pre-existing diabetes with glucose toxicity elevations ≥ grade 3
• Triglyceride or total cholesterol elevations ≥ grade 3
• Clinical or laboratory evidence of clinically significant liver impairment/ dysfunction, disease or cirrhosis.
• Life expectancy < 6 months in the opinion of the investigator.
• Active substance abuse or significant psychiatric illness that in the opinion of the investigator might interfere with study compliance.
• Female subject of childbearing potential not using effective non-hormonal birth control methods or not willing to continue practicing these birth control methods from screening until the last trial related activity.
• Subject is pregnant or lactating.
• Any condition that in the Principal Investigator's opinion may render the subject unable to complete the study or which may pose significant risk to the subject.